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Summary of Contents for DEPISTEO VISION SCREENER VT1
- Page 1 VISION SCREENER USER MANUAL ® DEPISTEO (LLC) +1 800 496 8290 309 East Paces Ferry NE, suite 400 contact@depisteo.com Atlanta, GA 30305 – USA...
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Page 2: Table Of Contents
FD1182.DOC.001 V02.01.00 ® February 2025 Table of Contents Information regulatory ............................5 1.1. Safety Warnings ............................5 1.2. Use planned ..............................5 1.3. Operators planned ............................5 1.4. Medical contraindications ..........................5 1.5. Benefits clinics and risks ..........................6 1.6. Incidents or risks of serious incidents ...................... - Page 3 FD1182.DOC.001 V02.01.00 ® February 2025 5.2. Using the remote control in manual mode ....................33 5.3. Using the remote control in sequence mode ..................... 34 5.4. Webapp Wifi Access Settings ........................34 5.5. Editing sequences via the Webapp ......................35 Description of the tests............................
- Page 4 FD1182.DOC.001 V02.01.00 ® February 2025 6.9.5. Instructions to give to the patient ...................... 53 6.10. Color perception test ..........................54 6.10.1. Purpose and presentation of the test ....................54 6.10.2. Running the test..........................54 6.10.3. Interface Description VisioWin® ......................55 6.10.4.
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Page 5: Information Regulatory
VT1® 4K must be placed on a flat and stable surface. The VT1® 4K is a fragile optical device and must be transported in the DEPISTEO trolley or, failing that, in its original packaging to protect it from vibrations and shocks. -
Page 6: Benefits Clinics And Risks
FD1182.DOC.001 V02.01.00 ® February 2025 Table 1Non-exhaustive list of examples of photosensitizing drugs Antibiotics Antifungals Antidepressants Doxycycline Griseofulvin Amitriptyline Ciprofloxacin Voriconazole Imipramine Levofloxacin Sertraline Sulfamethoxazole Antihistamines Non -steroidal anti- inflammatory drugs Diuretics Diphenhydramine Ibuprofen Hydrochlorothiazide Promethazine Naproxen Furosemide Piroxicam Drugs cardiovascular Drugs psychotropic drugs Drugs antidiabetics Amiodarone... -
Page 7: Technical Information
FD1182.DOC.001 V02.01.00 ® February 2025 2. Technical information 2.1. Materials provided VT1® 4K device : Removable front support IEC60601 Medical External Power Supply (Part No. Globtek GTM41060-2512) Microfiber cloth for cleaning glasses USB Type C to Type A Cable VisioWin® software (computerized version) Fact Sheet Remote control and CD input block (Only for remote control version) Optional: VisioClick®, a USB Type A to B cable, an Audio headset, a carrying case... - Page 8 FD1182.DOC.001 V02.01.00 ® February 2025 Removable forehead support and patient head presence detection zone Retractable goggle for central visual field testing Optics for distance and intermediate vision testing LED series for peripheral visual field testing Optics for near vision testing Ergonomic nasal location Non-slip weighted foot to ensure the stability of the device Location of connectors and on/off switch...
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Page 9: Technical Characteristics
FD1182.DOC.001 V02.01.00 ® February 2025 2.3. Technical characteristics 2.3.1. Features of the computerized or remote-controlled VT1® 4K Screen display TFT-LCD 5.46'' 4K 2160p (3840x2160) Backlight type Double (2 x 12 LED) Photopic 7.432 or 14.864 cd/ft² Brightness levels Mesopic 0.279 cd/ft² Depending on the versions: Near vision Intermediate vision... -
Page 10: Visiowin® Software
FD1182.DOC.001 V02.01.00 ® February 2025 2.3.2. VisioWin® software Software VisioWin® Minimum configuration Recommended configuration Operating system Windows 7, 8 or 8.1 Windows 10 or 11 Processor Pentium IV 2.8GHz Intel Core i3 or higher Architecture 64 bits 64 bits Memory 2GB RAM 4GB RAM Disk space... -
Page 11: Symbols
FD1182.DOC.001 V02.01.00 ® February 2025 2.5. Symbols Non-ionizing electromagnetic radiation (Wifi 2412 MHz - 2484 MHz) CE marking MDR 2017/745 Type B applied part Must not be disposed of as unsorted waste but treated in accordance with the Waste Electrical and Electronic Equipment (WEEE) Directive Consult the manual user Device medical... -
Page 12: Installation Of Vt1® 4K
FD1182.DOC.001 V02.01.00 ® February 2025 3. Installation of VT1® 4K 3.1. Unpacking the device To access the VT1® 4K open the box and remove the compartmentalized foam tray which contains the equipment listed in paragraph 2.1. Lift the VT1® 4K by the handle. The cardboard, foam cushioning and cables must be kept for maintenance shipments. -
Page 13: Computerized Version: First Start And Access To The Visiowin® Installer
FD1182.DOC.001 V02.01.00 ® February 2025 3.3. Computerized version: First start and access to the VisioWin® installer The VisioWin® software download link is provided in the Information Sheet supplied with the device. Once the VT1® 4K is connected to the PC, it is also possible to access the VisioWin® software installation executable file or the PDF version of the user manual by pressing the front support immediately after switching on the device. -
Page 14: Using The Computerized Vt1® 4K
FD1182.DOC.001 V02.01.00 ® February 2025 4. Using the computerized VT1® 4K 4.1. Tilt adjustment Before using the VT1® 4K with a patient, adjust the tilt while holding the foot. 4.2. Starting the software VisioWin® When starting, the VisioWin® software checks that all the technical prerequisites are met for optimal use of the functionalities. -
Page 15: Visiowin® Software Home Page
FD1182.DOC.001 V02.01.00 ® February 2025 4.3. VisioWin® Software Home Page 4.3.1. Interface Description user VisioWin® software interface is divided into different areas: (1) Identity of the patient who must undergo the examination (2) Patient Window: View and navigate between patient data. (3) Status bar: information relating to the hardware status of the VT1®... -
Page 16: Description Of Icons
FD1182.DOC.001 V02.01.00 ® February 2025 4.3.2. Description of icons Create or select a patient profile Show current review page Connected socket Plug disconnected Show manual user Access support options Access the settings pages Start a new exam with the selected patient Report The VT1®... -
Page 17: Software Setup Visiowin
FD1182.DOC.001 V02.01.00 ® February 2025 4.4. Software Setup VisioWin® 4.4.1. Settings generals Accessible from Settings in the side menu, the general settings allow you to define: The display mode of visual tests according to manual execution (see paragraph 4.6.2) or by sequence (see paragraph 4.6.3) of vision tests. -
Page 18: Settings Authentication
FD1182.DOC.001 V02.01.00 ® February 2025 4.4.3. Settings authentication Authentication settings allow you to define the secure connection method to the software. It is possible to disable password-protected access to the software by unchecking the Use box a username and password. In order to ensure the protection of patient data, it is strongly recommended not to deactivate access control to the VisioWin®... -
Page 19: Data
Data exchange mode with the EMR with a secure exchange protocol. If you want EMR compatibility, make sure the box is checked. Login is done by entering the username and password you use when you normally log in to your business software. Contact DEPISTEO for further information. -
Page 20: User Management
FD1182.DOC.001 V02.01.00 ® February 2025 4.4.5. User Management Profile directory management allows you to view, create and modify user profiles. To add a new user, click New To edit the user profile: click Edit To delete the user profile: click Delete The edit functionality allows you to edit all the information previously entered using the forms below. -
Page 21: Editing Sequences
FD1182.DOC.001 V02.01.00 ® February 2025 4.4.6. Editing sequences By default, several sequences are available in VisioWin®, which can be modified or supplemented with new sequences. Create a new sequence Rename the sequence selected Clone the selected sequence Delete sequence selected Click on the sequence creation button, select the first test to be carried out, the vision, distance and lighting conditions then validate by clicking on Add. -
Page 22: Scoring Parameters
FD1182.DOC.001 V02.01.00 ® February 2025 4.4.7. Scoring parameters Scoring profiles allow you to define success thresholds for each type of test. Similar to Sequences, Scores can be created, renamed, cloned and deleted using the same context bar icons. Use the Add and Remove buttons to complete the list of tests to which to apply the scores. The scores must then be defined according to the scales of results expected for each test. -
Page 23: Visioclick® Settings
FD1182.DOC.001 V02.01.00 ® February 2025 4.4.9. VisioClick® Settings VisioClick® automation settings page allows you to do the following: Change the language preselection for voice instructions: Add a language from the list of available languages by clicking Add. Remove a language from the list of loaded languages by clicking Remove. Select the language to be broadcast by default in the headset Set default headset volume Click Update to validate the new configuration to be applied. -
Page 24: Patient Profile Management
FD1182.DOC.001 V02.01.00 ® February 2025 4.5. Patient profile management 4.5.1. Patient profile management (excluding third-party software interface) To save the results of an examination in the local database of the PC (excluding third-party software), it is necessary to first create a patient profile or select an existing patient. From the side menu, click on the patient icon to access the patient profile viewing interface. -
Page 25: Patient Profile Management (Third-Party Software Interface)
FD1182.DOC.001 V02.01.00 ® February 2025 4.5.2. Patient profile management (third-party software interface) When your EMR box is checked (see paragraph 4.4.1.3.), to save the results of an examination in the database of your EMR (third-party software), it is necessary to select an existing patient in the database of your EMR. From the side menu click on the patient icon to access the patient profile viewing interface. -
Page 26: Conducting A New Exam
FD1182.DOC.001 V02.01.00 ® February 2025 4.6. Conducting a new exam 4.6.1. Precautions of use The operation of the device is based on binocular fusion. The operator must ensure that the patient has sufficient fusion to perform the examination. Before any examination, the patient should be asked if he or she usually wears optical correction. For photosensitive patients the light level can be reduced at any time during a test. - Page 27 FD1182.DOC.001 V02.01.00 ® February 2025 The icon allows you to launch a test manually in the appropriate viewing mode. Visual tests can be performed spontaneously and in a targeted manner provided that the display of all tests is activated in the general settings (see paragraph 4.4.1) or in a sequenced manner according to a predefined order in the sequence editor (see paragraph 0).
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Page 28: Using Test Sequences
FD1182.DOC.001 V02.01.00 ® February 2025 Visualization of scoring During and after the exam, the result is reported in the corresponding test sticker. scoring parameter is active, the validation or not of the predefined criterion is indicated respectively by a green check mark or a red cross. -
Page 29: Autorun With Visioclick
Although the VisioClick® device gives the patient a certain autonomy, a healthcare professional must always be present in the immediate vicinity to ensure that the examination goes smoothly. For reasons of hygiene and biocompatibility, it is mandatory to use single-use hygienic caps from the DEPISTEO brand. - Page 30 FD1182.DOC.001 V02.01.00 ® February 2025 Click on the toolbar icon to start the sequence in automatic mode. The sequence begins with a test of understanding the vocal instructions. Tests can also be run selectively in automatic mode. Refer to paragraph 0for more details on the automatic mode icons. Note: If the headset is accidentally disconnected, the examination is interrupted and the patient is notified.
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Page 31: Visualizing The Results Of Examination
Click on Report to access the PDF report viewer. Gateway software allows you to export results in PDF format to most third-party software. Contact DEPISTEO for further information on Gateway software features. -
Page 32: Using The Remote-Controlled Vt1® 4K
FD1182.DOC.001 V02.01.00 ® February 2025 5. Using the remote-controlled VT1® 4K 5.1. Performing a remote-controlled examination 5.1.1. Remote control start Connect the VT1® 4K with the power supply and connect the remote control to the VT1® 4K using the USB type C cable. -
Page 33: Using The Response Block
FD1182.DOC.001 V02.01.00 ® February 2025 5.1.2. Using the response block The answer block can be downloaded from the link provided in the Information Sheet supplied with the unit. The results of the various tests carried out manually or in sequence can be reported by hand on the answer block. 5.2. -
Page 34: Using The Remote Control In Sequence Mode
FD1182.DOC.001 V02.01.00 ® February 2025 5.3. Using the remote control in sequence mode Sequence mode gives access to all the sequences pre-recorded on the remote control. Click the next/previous arrows located in the upper corners of the screen to move forward or backward through the test sequence. -
Page 35: Editing Sequences Via The Webapp
FD1182.DOC.001 V02.01.00 ® February 2025 5.5. Editing sequences via the Webapp (1) Create a new sequence (2) Clone the selected sequence (3) Delete selected sequence (4) Choose the desired sequence from the drop-down list (5) Rename the selected sequence (6) Save changes to the sequence Click on the sequence creation button, select the first test to be carried out, the vision, distance and lighting conditions then validate by clicking on “Add”. -
Page 36: Description Of The Tests
FD1182.DOC.001 V02.01.00 ® February 2025 6. Description of the tests 6.1. Test Library The VT1® 4K is configured with a test library, also called a test pack. Table 1: Configurations for visual acuity test packs Test Pack – Visual Acuity •... - Page 37 FD1182.DOC.001 V02.01.00 ® February 2025 Table 2: Configurations for special test packs Test Pack – Special Tests • • • • • • • • • • • Visual field complete • • • • • • Duochrome red/green • •...
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Page 38: Acuity Tests Visual
FD1182.DOC.001 V02.01.00 ® February 2025 6.2. Acuity tests visual 6.2.1. Purpose and presentation of the test The visual acuity test is the starting point of any eye examination. It ensures that a patient has the correct correction and assesses their ability to decipher information from everyday life. During an examination, we generally aim to achieve a visual acuity of 10/10, or even 12/10. -
Page 39: Interface Description Visiowin
FD1182.DOC.001 V02.01.00 ® February 2025 6.2.3. Interface Description VisioWin® The visual acuity tests are split into as many vignettes as there are distance situations (near, intermediate, far) lighting (photopic/mesopic) to be tested. Click on the symbols at the bottom left of the thumbnail to vary the test conditions: with/without correction, optotype model (ABC/123/C/Symbols). -
Page 40: Instructions To Give To The Patient
FD1182.DOC.001 V02.01.00 ® February 2025 6.2.5. Instructions to give to the patient Depending on the type of optotype selected, ask the following question: Letters: “On the smallest possible line, read all the letters” Numbers: “On the smallest possible line, read all the numbers” Landolt : "On the smallest possible line, say on which side the opening of the ring is located."... -
Page 41: Interface Description Visiowin
FD1182.DOC.001 V02.01.00 ® February 2025 6.3.3. Interface Description VisioWin® The thumbnail shows the contrast gradient as seen by the patient and the exam result as a percentage. The viewing distance can be changed. In the response entry window, click on the optotypes correctly recognized by the patient. -
Page 42: Astigmatism Test
FD1182.DOC.001 V02.01.00 ® February 2025 6.4. Astigmatism test 6.4.1. Purpose and presentation of the test This test is used to detect a defect of astigmatism in a patient. Astigmatism is due to a bad relationship between the power of the eye and its length. The vision of the astigmatic will then be distorted in a particular direction. If the astigmatism is too great, the patient will have poor acuity at all distances. -
Page 43: Interface Description Remote
FD1182.DOC.001 V02.01.00 ® February 2025 6.4.4. Interface Description Remote The remote control interface allows you to view the conditions of the current test: Display brightness level Viewing distance Viewing mode requested Question to ask Optotypes displayed State the question and note the perceived result on the response form. -
Page 44: Visual Field Test Complete
FD1182.DOC.001 V02.01.00 ® February 2025 6.5. Visual field test complete 6.5.1. Purpose and presentation of the test The visual field can highlight various vision disorders. It is essential for diagnosing vision holes due to scotomas, optic nerve damage or directly at the level of the cerebral cortex. The table below shows us the extent of the visual field measurable by the VT1®... -
Page 45: Running The Test
FD1182.DOC.001 V02.01.00 ® February 2025 The peripheral field is tested using 10 diodes per eye. They are arranged as follows: ✓ Nasal: 50° ✓ Temporal: 30°, 45°, 60°, 75°, 90° ✓ High: 22°, 30° ✓ Low: 22°, 30° The central field will test the central 30° of vision using 32 diodes per eye. They are arranged in the manner of an Esterman grid , which will give more importance to low vision as well as the horizon line. -
Page 46: Interface Description Remote
FD1182.DOC.001 V02.01.00 ® February 2025 6.5.4. Interface Description Remote The remote control interface allows you to view the different diodes in the peripheral field as well as the corresponding angles. Press the different circles to light up the associated diode and note on the response form whether the patient perceived the light emitted by the diode. -
Page 47: Relief Test - Stereoscopy
FD1182.DOC.001 V02.01.00 ® February 2025 6.6. Relief test – Stereoscopy 6.6.1. Purpose and presentation of the test This test is useful to check the quality of stereoscopic vision which is essential for good binocular vision. It is this acuity which allows for depth vision and comparison of the proximity of objects between them. A problem with stereopsis can reveal certain disorders such as anisometropia , amblyopia, strabismus or image suppression problems. -
Page 48: Interface Description Visiowin
FD1182.DOC.001 V02.01.00 ® February 2025 6.6.3. Interface Description VisioWin® thumbnail shows geometric shapes relief perceived by the patient and the corresponding level of shift in arc seconds ( '' ). The viewing distance can be changed. In the response entry window, click on the geometric shapes perceived as offset, “in relief”, by the patient. -
Page 49: Phoria Test
FD1182.DOC.001 V02.01.00 ® February 2025 6.7. Phoria test 6.7.1. Purpose and presentation of the test The phoria test is used to highlight the tendency of an eye to deviate from its binocular fixation position in the absence of a fusional stimulus. We also speak of heterophorias or dissociated phorias, which are measured in prismatic diopters (∆). -
Page 50: Interface Description Visiowin
FD1182.DOC.001 V02.01.00 ® February 2025 6.7.3. Interface Description VisioWin® The thumbnail shows the grid of nine boxes displayed to the patient and the trend associated with the result entered. The viewing distance can be changed. In the response entry window, click on the box in which the patient sees the white dot. -
Page 51: Fusion Test
FD1182.DOC.001 V02.01.00 ® February 2025 6.8. Fusion test 6.8.1. Purpose and presentation of the test The purpose of this test is to check the patient's binocular vision. It is known as the Worth test. It will allow us to know if the patient's brain is able to fuse the images from the right eye with those from the left eye. Fusion requires good visual acuity in each eye. -
Page 52: Interface Description Remote
FD1182.DOC.001 V02.01.00 ® February 2025 6.8.4. Interface Description Remote The remote control interface allows you to view the conditions of the current test: Display brightness level Viewing distance Question to ask State the question and note the perceived result on the response form. 6.8.5. -
Page 53: Running The Test
FD1182.DOC.001 V02.01.00 ® February 2025 6.9.2. Running the test ✓ This test is done monocularly. ✓ This test should be performed with patient compensation. ✓ This test must be performed in photopic mode 6.9.3. Interface Description VisioWin® The thumbnail shows the results for each eye tested. -
Page 54: Color Perception Test
FD1182.DOC.001 V02.01.00 ® February 2025 6.10. Color perception test 6.10.1. Purpose and presentation of the test This color perception test, consisting of a set of pseudo-isochromatic plates, allows the detection of color vision abnormalities, and mainly Protan , Deutan and Tritan type dyschromatopsias. Reading the numbers on all the plates allows us to know the state of a subject's color perception and can reveal difficulties in recognizing certain numbers and therefore certain colors. -
Page 55: Interface Description Visiowin
FD1182.DOC.001 V02.01.00 ® February 2025 6.10.3. Interface Description VisioWin® thumbnail shows color numbers to be identified by the patient for each vision mode. The check boxes represent the numbers perceived or not by the patient. The viewing distance can be changed. In the response entry window, check boxes corresponding... -
Page 56: Glare Resistance Test
FD1182.DOC.001 V02.01.00 ® February 2025 6.11. Glare resistance test VT1® 4K glare tests should not be performed on photosensitive patients who have recently taken photosensitizing medication. Medical contraindications to performing this test are detailed in paragraph 1.4 This test is not available with the remote control version. 6.11.1. -
Page 57: Instructions To Give To The Patient
FD1182.DOC.001 V02.01.00 ® February 2025 6.11.4. Instructions to give to the patient Step 1 – Patient adaptation Step 2 – Acuity Before glare The Amsler grid is displayed in mesopic brightness for Ask the patient to read the optotypes from the a duration of 10 seconds. -
Page 58: Glare Sensitivity Test
FD1182.DOC.001 V02.01.00 ® February 2025 6.12. Glare sensitivity test VT1® 4K glare tests should not be performed on photosensitive patients who have recently taken photosensitizing medication. Medical contraindications to performing this test are detailed in paragraph 1.4 This test is not available in a remote-controlled or automated version with VisioClick®. 6.12.1. -
Page 59: Interface Description Visiowin
FD1182.DOC.001 V02.01.00 ® February 2025 6.12.3. Interface Description VisioWin® The thumbnail shows the driving situation displayed to the patient, the visual elements perceived are colored green. The test completion time is also visible. Viewing, distance or lighting conditions cannot be changed for this test. -
Page 60: Vt1® 4K Maintenance
Periodic maintenance Annual maintenance of the VT1® 4K is recommended for verification and calibration of the display screen and glare LEDs. Only DEPISTEO and its authorized distributors are authorized to carry out maintenance. 7.3. Support from the software Visiowin From the side menu click on the icon Help to access maintenance information for VisioWin®... -
Page 61: Disposal
(paragraph 7.1), maintenance (paragraph 7.2) and environmental conditions (paragraph 2.3.1). No liability for the lack of performance of the device can be attributed to DEPISTEO in the event of non-compliance by the user with the maintenance recommendations and conditions of use. -
Page 62: Problem Solving
The database is not read/write accessible. If the problem persists, or for any other problem, contact DEPISTEO or your authorized distributor. For quick troubleshooting, it will be helpful to provide system information or event logs available from the VisioWin® help page (see paragraph 7.3).
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